Application 050582

Type: NDA
Sponsor: MAYNE PHARMA INTL

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	DORYX	DOXYCYCLINE HYCLATE	CAPSULE, DELAYED RELEASE;ORAL	EQ 100MG BASE	Yes	No
002	DORYX	DOXYCYCLINE HYCLATE	CAPSULE, DELAYED RELEASE;ORAL	EQ 75MG BASE	Yes	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N050582-001	DORYX	DOXYCYCLINE HYCLATE	EQ 100MG BASE	CAPSULE, DELAYED RELEASE / ORAL		RLD	1985-07-22
N050582-002	DORYX	DOXYCYCLINE HYCLATE	EQ 75MG BASE	CAPSULE, DELAYED RELEASE / ORAL		RLD	2001-08-13

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 3 · 86 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	N050582-001	DORYX	EQ 100MG BASE	CAPSULE, DELAYED RELEASE / ORAL	RLD	1985-07-22	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N050582-002	DORYX	EQ 75MG BASE	CAPSULE, DELAYED RELEASE / ORAL	RLD	2001-08-13	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N050582-001	DORYX	EQ 100MG BASE	CAPSULE, DELAYED RELEASE / ORAL	RLD	1985-07-22	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N050582-002	DORYX	EQ 75MG BASE	CAPSULE, DELAYED RELEASE / ORAL	RLD	2001-08-13	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N050582-001	DORYX	EQ 100MG BASE	CAPSULE, DELAYED RELEASE / ORAL	RLD	1985-07-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N050582-002	DORYX	EQ 75MG BASE	CAPSULE, DELAYED RELEASE / ORAL	RLD	2001-08-13	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N050582-001	DORYX	EQ 100MG BASE	CAPSULE, DELAYED RELEASE / ORAL	RLD	1985-07-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N050582-002	DORYX	EQ 75MG BASE	CAPSULE, DELAYED RELEASE / ORAL	RLD	2001-08-13	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N050582-001	DORYX	EQ 100MG BASE	CAPSULE, DELAYED RELEASE / ORAL	RLD	1985-07-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N050582-002	DORYX	EQ 75MG BASE	CAPSULE, DELAYED RELEASE / ORAL	RLD	2001-08-13	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N050582-001	DORYX	EQ 100MG BASE	CAPSULE, DELAYED RELEASE / ORAL	RLD	1985-07-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N050582-002	DORYX	EQ 75MG BASE	CAPSULE, DELAYED RELEASE / ORAL	RLD	2001-08-13	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N050582-001	DORYX	EQ 100MG BASE	CAPSULE, DELAYED RELEASE / ORAL	RLD	1985-07-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N050582-002	DORYX	EQ 75MG BASE	CAPSULE, DELAYED RELEASE / ORAL	RLD	2001-08-13	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N050582-001	DORYX	EQ 100MG BASE	CAPSULE, DELAYED RELEASE / ORAL	RLD	1985-07-22	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N050582-002	DORYX	EQ 75MG BASE	CAPSULE, DELAYED RELEASE / ORAL	RLD	2001-08-13	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N050582-001	DORYX	EQ 100MG BASE	CAPSULE, DELAYED RELEASE / ORAL	RLD	1985-07-22	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N050582-002	DORYX	EQ 75MG BASE	CAPSULE, DELAYED RELEASE / ORAL	RLD	2001-08-13	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N050582-001	DORYX	EQ 100MG BASE	CAPSULE, DELAYED RELEASE / ORAL	RLD	1985-07-22	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N050582-002	DORYX	EQ 75MG BASE	CAPSULE, DELAYED RELEASE / ORAL	RLD	2001-08-13	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N050582-001	DORYX	EQ 100MG BASE	CAPSULE, DELAYED RELEASE / ORAL	RLD	1985-07-22	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N050582-002	DORYX	EQ 75MG BASE	CAPSULE, DELAYED RELEASE / ORAL	RLD	2001-08-13	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N050582-001	DORYX	EQ 100MG BASE	CAPSULE, DELAYED RELEASE / ORAL	RLD	1985-07-22	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N050582-002	DORYX	EQ 75MG BASE	CAPSULE, DELAYED RELEASE / ORAL	RLD	2001-08-13	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N050582-001	DORYX	EQ 100MG BASE	CAPSULE, DELAYED RELEASE / ORAL	RLD	1985-07-22	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N050582-002	DORYX	EQ 75MG BASE	CAPSULE, DELAYED RELEASE / ORAL	RLD	2001-08-13	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N050582-001	DORYX	EQ 100MG BASE	CAPSULE, DELAYED RELEASE / ORAL	RLD	1985-07-22	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N050582-002	DORYX	EQ 75MG BASE	CAPSULE, DELAYED RELEASE / ORAL	RLD	2001-08-13	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N050582-001	DORYX	EQ 100MG BASE	CAPSULE, DELAYED RELEASE / ORAL	RLD	1985-07-22	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N050582-002	DORYX	EQ 75MG BASE	CAPSULE, DELAYED RELEASE / ORAL	RLD	2001-08-13	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N050582-001	DORYX	EQ 100MG BASE	CAPSULE, DELAYED RELEASE / ORAL	RLD	1985-07-22	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N050582-002	DORYX	EQ 75MG BASE	CAPSULE, DELAYED RELEASE / ORAL	RLD	2001-08-13	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N050582-001	DORYX	EQ 100MG BASE	CAPSULE, DELAYED RELEASE / ORAL	RLD	1985-07-22	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N050582-002	DORYX	EQ 75MG BASE	CAPSULE, DELAYED RELEASE / ORAL	RLD	2001-08-13	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N050582-001	DORYX	EQ 100MG BASE	CAPSULE, DELAYED RELEASE / ORAL	RLD	1985-07-22	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N050582-002	DORYX	EQ 75MG BASE	CAPSULE, DELAYED RELEASE / ORAL	RLD	2001-08-13	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N050582-001	DORYX	EQ 100MG BASE	CAPSULE, DELAYED RELEASE / ORAL	RLD	1985-07-22	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N050582-002	DORYX	EQ 75MG BASE	CAPSULE, DELAYED RELEASE / ORAL	RLD	2001-08-13	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N050582-001	DORYX	EQ 100MG BASE	CAPSULE, DELAYED RELEASE / ORAL	RLD	1985-07-22	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N050582-002	DORYX	EQ 75MG BASE	CAPSULE, DELAYED RELEASE / ORAL	RLD	2001-08-13	`74a2ff9319b5…`

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 2 of 7 · 140 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
DOXYCYCLINE HYCLATE	DOXYCYCLINE HYCLATE	Strides Pharma Science Limited	2deeee4f-b342-a178-e063-6394a90af897	2026-06-26	Warnings, Adverse reactions	Name fallback generic name: DOXYCYCLINE HYCLATE
DOXYCYCLINE HYCLATE	DOXYCYCLINE HYCLATE	Strides Pharma Science Limited	b8b76aaa-575b-497f-b854-c42bc992c784	2026-06-26	Warnings, Adverse reactions	Name fallback generic name: DOXYCYCLINE HYCLATE
DOXYCYCLINE HYCLATE	DOXYCYCLINE HYCLATE	St. Mary's Medical Park Pharmacy	02f87c60-8425-1a1e-e063-6294a90a0c94	2026-06-25	Warnings, Adverse reactions	Name fallback generic name: DOXYCYCLINE HYCLATE
doxycycline hyclate	DOXYCYCLINE HYCLATE	Slate Run Pharmaceuticals, LLC	f31e69fc-e513-40e4-91b5-22ccf1ed9437	2026-06-23	Warnings, Adverse reactions	Name fallback generic name: DOXYCYCLINE HYCLATE
Doxycycline Hyclate	DOXYCYCLINE HYCLATE	Unit Dose Solutions, Inc.	548d4218-2feb-8716-e063-6394a90afbe3	2026-06-18	Warnings, Adverse reactions	Name fallback generic name: DOXYCYCLINE HYCLATE
Doxycycline	DOXYCYCLINE HYCLATE	PD-Rx Pharmaceuticals, Inc.	c96d3986-9d92-4ec4-a319-a50aeb2f4fe7	2026-06-12	Warnings, Adverse reactions	Name fallback generic name: DOXYCYCLINE HYCLATE
Doxycycline Hyclate	DOXYCYCLINE HYCLATE	PD-Rx Pharmaceuticals, Inc.	e24a3292-0d4f-4692-8cf7-a82bd19e5932	2026-06-08	Warnings, Adverse reactions	Name fallback generic name: DOXYCYCLINE HYCLATE
Doxycycline Hyclate	DOXYCYCLINE HYCLATE	PD-Rx Pharmaceuticals, Inc.	5f523294-e62b-4da5-8799-047d4bed966f	2026-06-04	Warnings, Adverse reactions	Name fallback generic name: DOXYCYCLINE HYCLATE
Doxycycline Hyclate	DOXYCYCLINE HYCLATE	Sun Pharmaceutical Industries, Inc.	214a9cfe-a522-4022-81d4-e59f447401fe	2026-06-03	Warnings, Adverse reactions	Name fallback generic name: DOXYCYCLINE HYCLATE
Doxycycline Hyclate	DOXYCYCLINE HYCLATE	Coupler LLC	52ba329a-8cb3-cf30-e063-6394a90aa0dc	2026-05-26	Warnings, Adverse reactions	Name fallback generic name: DOXYCYCLINE HYCLATE
Doxycycline Hyclate	DOXYCYCLINE HYCLATE	REMEDYREPACK INC.	3a85933f-bd73-4ad7-968d-c90cb7c7a60c	2026-05-13	Warnings, Adverse reactions	Name fallback generic name: DOXYCYCLINE HYCLATE
Doxycycline Hyclate	DOXYCYCLINE HYCLATE	Alembic Pharmaceuticals Inc.	3ae4ca12-be39-46b9-bc4c-f8356776c175	2026-04-28	Warnings, Adverse reactions	Name fallback generic name: DOXYCYCLINE HYCLATE
Doxycycline Hyclate	DOXYCYCLINE HYCLATE	Cardinal Health 107, LLC	a34fbbc7-09dc-42d6-a075-f4ea8f170ba7	2026-04-24	Warnings, Adverse reactions	Name fallback generic name: DOXYCYCLINE HYCLATE
DOXYCYCLINE HYCLATE	DOXYCYCLINE HYCLATE	Bryant Ranch Prepack	7a915c50-6fce-45e6-9554-677bb09a868d	2026-04-13	Warnings, Adverse reactions	Name fallback generic name: DOXYCYCLINE HYCLATE
DOXYCYCLINE HYCLATE	DOXYCYCLINE HYCLATE	Cranbury Pharmaceuticals, LLC	fe6985d2-37f7-4277-94a9-f7125b4b3fd7	2026-03-31	Warnings, Adverse reactions	Name fallback generic name: DOXYCYCLINE HYCLATE
Doxycycline Hyclate	DOXYCYCLINE HYCLATE	Direct_Rx	2ad2b85f-2479-c7cd-e063-6294a90acca1	2026-03-06	Warnings, Adverse reactions	Name fallback generic name: DOXYCYCLINE HYCLATE
DOXYCYCLINE HYCLATE	DOXYCYCLINE HYCLATE	DIRECT RX	9798c4de-8af7-41c4-acc2-1e9775194297	2026-03-05	Warnings, Adverse reactions	Name fallback generic name: DOXYCYCLINE HYCLATE
doxycycline hyclate	DOXYCYCLINE HYCLATE	Bryant Ranch Prepack	0aaa4ff7-7fba-4a40-9b49-82e4da68a48f	2026-03-02	Warnings, Adverse reactions	Name fallback generic name: DOXYCYCLINE HYCLATE
Doxycycline Hyclate	DOXYCYCLINE HYCLATE	American Health Packaging	10988250-b267-4f10-b264-5f127cc1ae18	2026-02-23	Warnings, Adverse reactions	Name fallback generic name: DOXYCYCLINE HYCLATE
DORYX MPC	DOXYCYCLINE HYCLATE	Mayne Pharma Commercial LLC	f9277bb8-982d-444d-9325-35d5c53a2d35	2026-02-16	Warnings, Adverse reactions	Name fallback generic name: DOXYCYCLINE HYCLATE

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Documents#

Document, Submission type, Date table
Document	Submission type	Date
81851	SUPPL	2025-04-08
81806	SUPPL	2025-04-02
62032	SUPPL	2020-03-04
62024	SUPPL	2020-03-04
52511	SUPPL	2018-02-08
52506	SUPPL	2018-02-08
39002	SUPPL	2015-09-04
30112	SUPPL	2015-09-04
30111	SUPPL	2011-03-24
39001	SUPPL	2008-02-14
7844	SUPPL	2008-02-13
39000	SUPPL	2005-05-17
7843	SUPPL	2005-05-17
30110	SUPPL	2004-02-27
30109	SUPPL	2003-06-08
7842	SUPPL	2002-06-18